Diprosone

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Betamethasone dipropionate 0.065% w/w equivalent to 0.05% betmethasone;  ; Betamethasone dipropionate 0.64 mg/g equivalent to 0.05% betmethasone
Available from:
Merck Sharp & Dohme (New Zealand) Limited
INN (International Name):
Betamethasone dipropionate 0.065% w/w (= 0.05% betmethasone)
Dosage:
0.05% w/w
Pharmaceutical form:
Topical cream
Composition:
Active: Betamethasone dipropionate 0.065% w/w equivalent to 0.05% betmethasone   Excipient: Cetomacrogol 1000 Cetostearyl alcohol Chlorocresol Liquid paraffin Monobasic sodium phosphate dihydrate Phosphoric acid Purified water White soft paraffin Active: Betamethasone dipropionate 0.64 mg/g equivalent to 0.05% betmethasone Excipient: Cetomacrogol 1000 Cetostearyl alcohol Chlorocresol Liquid paraffin Monobasic sodium phosphate dihydrate Phosphoric acid Purified water Sodium hydroxide White soft paraffin
Units in package:
Tube, 15g, 15 g
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Crystal Pharma SA
Product summary:
Package - Contents - Shelf Life: Tube, - 15 g - 24 months from date of manufacture stored at or below 25°C - Tube, - 50 g - 24 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-2441
Authorization date:
1976-06-10

DIPROSONE

DIPROSONE

®

Betamethasone dipropionate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Diprosone.

It does not contain all the available

information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using Diprosone

against the benefits it is expected to

have for you.

If you have any concerns about this

medicine, ask your doctor or

pharmacist.

Keep this leaflet with your

medicine.

You may need to read it again.

What Diprosone is

used for

The name of your medicine is

Diprosone. It contains the active

ingredient called betamethasone

dipropionate.

It is a type of cortisone and belongs

to the group of medicines called

corticosteroids. Diprosone is

classified as a high potency topical

corticosteroid.

There are three forms of Diprosone:

cream, ointment and lotion.

Diprosone is used on the skin to

relieve the redness, swelling, itching

and discomfort of many skin

problems such as:

psoriasis (a stubborn skin

disorder with raised, rough,

reddened areas covered with dry,

fine silvery scales)

eczema (an often itchy skin

condition with redness, swelling,

oozing of fluid, crusting which

may lead to scaling)

other types of dermatitis

Diprosone Lotion is also used on the

scalp and hairy parts of the body.

Your doctor may have prescribed

Diprosone for another reason.

Ask your doctor if you have any

questions about why Diprosone has

been prescribed for you.

This medicine is available only with

a doctor's prescription.

Before you use

Diprosone

When you must not use it

Do not use Diprosone if you have

had an allergic reaction, such as

wheezing, rash or hives, to

Diprosone, any other

corticosteroid, or any of the

ingredients listed at the end of this

leaflet.

Do not use Diprosone if you have:

a viral skin infection, such as

cold sores, shingles or chicken

pox

a fungal skin infection, such as

thrush, tinea or ringworm

tuberculosis of the skin

acne rosacea

inflammation around the

mouth

skin conditions with ulcers

unless your doctor tells you.

Ask your doctor to be sure you do

not have any of these conditions.

Do not use Diprosone just before

having a bath, shower or going

swimming.

If you do, you may reduce the

effectiveness of Diprosone.

Do not use Diprosone after the

expiry date (EXP) printed on the

pack has passed.

If you use Diprosone after the expiry

date has passed, it may not work as

well.

Do not use Diprosone if the

packaging shows signs of

tampering.

Before you start to use it

Tell your doctor or pharmacist if

you have allergies to:

any other medicines

any other substances, such as

foods, dyes or preservatives.

Tell your doctor if:

you are pregnant or breast

feeding.

Your doctor will tell you if you

can use Diprosone during

pregnancy or while you are breast

feeding.

you have any other medical

conditions, especially if you

have an infection.

Using other medicines

Tell your doctor or pharmacist if

you are using other creams,

ointments or lotions or taking any

other medicines. This includes any

that you buy without a

DIPROSONE

prescription from a pharmacy,

supermarket or health food shop.

How to use

DIPROSONE

How to use it

Apply a thin film of Diprosone

Cream or Ointment or a few drops

of Diprosone Lotion to the affected

skin or scalp twice daily. Massage

gently until it disappears. For

some patients, once daily

application may be enough for

maintenance therapy.

It is important to use Diprosone

exactly as your doctor has told you.

If you use it less often than you

should, it may not work as well and

your skin problem may not improve.

Using it more often than you should

may not improve your skin problem

any faster and may cause or increase

side effects.

How long to use it

Do not use Diprosone for more

than four weeks at a time unless

your doctor tells you.

If you forget to use it

If you forget to use Diprosone, use

it as soon as you remember and

then go back to your normal time

for applying Diprosone. Do not try

to make up for the amount you

missed by using more than you

would normally.

If you swallow it

Telephone your doctor or Poisons

Information Centre (Australia -

Ph: 13 11 26; New Zealand - Ph:

0800 POISON or 0800 764766) or

go to the accident and emergency

centre at your nearest hospital

immediately if you think that you

or anyone may have swallowed

Diprosone.

Keep the telephone numbers of

these places handy.

While you are using

Diprosone

Things you must do

Tell all doctors and pharmacists

who are treating you that you are

using Diprosone.

Tell your doctor if you feel that

Diprosone is not helping your

condition or if your skin condition

worsens or seems infected.

Tell your doctor if, for any reason,

you have not used Diprosone

exactly as prescribed.

Otherwise, your doctor may think

that it was not effective and change

your treatment unnecessarily.

If you become pregnant while

using Diprosone, tell your doctor.

Things you must not do

Do not use Diprosone under

dressings or on large areas of skin

unless your doctor tells you.

Do not use plastic pants or tight

fitting nappies if Diprosone is to be

used on the nappy area of young

children.

Do not use Diprosone in or near

the eyes.

Do not give Diprosone to anyone

else even if their symptoms seem

similar to yours.

Do not use Diprosone to treat other

conditions unless your doctor tells

you.

Your doctor has prescribed

Diprosone specially for you and your

condition. If you use it for another

condition, it may not work or make

the condition worse.

Things to be careful of

Do not use large amounts for a

long time.

If you use large amounts for a long

time, the chance of absorption

through the skin and the chance of

side effects increases.

Only use Diprosone on skin areas

that rub together such as under the

arm or in the groin area if your

doctor tells you.

Only use Diprosone on the face if

your doctor tells you. If

improvement does not occur within

one week, tell your doctor.

Children and adolescents should be

followed closely by the doctor, since

this medicine is absorbed through the

skin and can affect growth or cause

other unwanted effects.

Side Effects

Tell your doctor if you do not feel

well while you are using Diprosone.

Diprosone helps most people with

skin problems but it may have

unwanted side effects in a few

people.

Diprosone is generally well tolerated.

However, unwanted effects that have

been reported by some people using

Diprosone include:

burning

itching

irritation

infection or dryness of skin

irritation or redness of the face

increased hair growth

acne

change in skin colour

thinning of skin with easy

bruising

stretch marks

infection of the hair roots

rash around mouth area

contact dermatitis

heat rash

visual disturbances or blurred

vision

Mild temporary stinging may be

expected when Diprosone Lotion is

applied.

Diprosone may cause other side

effects.

DIPROSONE

Side effects that may happen with

oral or injectables corticosteroids

may also occur with corticosteroids

used on the skin, especially in infants

and children.

If you have any other side effects,

check with your doctor.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

After using Diprosone

Storage

Keep Diprosone in a cool dry place

where the temperature stays below

25°C. Diprosone Lotion should be

protected from light.

Do not store Diprosone or any

other medicines in the bathroom or

near the sink. Do not leave it in the

car or on window sills.

Heat and dampness can destroy some

medicines.

Keep Diprosone where children

cannot reach it. Keep the medicine

away from pets.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

using Diprosone or it has passed its

expiry date, ask your pharmacist

what to do with any that is left

over.

Product Description

What it looks like

Diprosone Cream is a white to off-

white cream. It is packed in 15 g and

50 g tubes.

Diprosone Ointment is a white to off-

white ointment. It is packed in 15 g

and 50 g tubes.

Diprosone Lotion is a colourless to

light yellow lotion. It is packed in 30

mL bottles.

Ingredients

Diprosone Cream contains:

betamethasone as dipropionate

0.5 mg/g

chlorocresol (preservative)

soft white paraffin

cetostearyl alcohol

liquid paraffin

cetomacrogol 1000

sodium phosphate - monobasic

dihydrate

phosphoric acid

purified water

Diprosone Ointment contains:

betamethasone as dipropionate

0.5 mg/g

liquid paraffin

soft white paraffin

Diprosone Lotion contains:

betamethasone as dipropionate

0.5 mg/g

isopropyl alcohol

carbomer

sodium hydroxide

purified water

Supplier

In Australia:

Merck Sharp & Dohme (Australia)

Pty Limited

Level 1, Building A, 26 Talavera

Road, Macquarie Park, NSW 2113

AUSTRALIA

Presentations:

Cream - AUST R 18818

Ointment - AUST R 144098

Lotion - AUST R 18829

In New Zealand:

Merck Sharp & Dohme (New

Zealand) Limited

PO Box 99851

Newmarket

Auckland

NEW ZEALAND

Presentations:

Cream

Ointment

Date of Preparation

03 November 2017

S-CCDS-MK1460-DPS-MTL-

082017

S-CCDS-MK1460-DPS-MTL-082017

DATA SHEET

1.

DIPROSONE

®

DIPROSONE (0.05% w/w) cream

DIPROSONE (0.05% w/w) ointment

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Betamethasone dipropionate equivalent to betamethasone 0.5mg/g (0.05% w/w).

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

DIPROSONE Cream is a white cream in a paraben-free water-washable vanishing cream base.

DIPROSONE Ointment is an off-white ointment in a preservative-free ointment base.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

DIPROSONE is indicated for the relief of inflammatory and pruritic manifestations of

corticosteroid-responsive dermatoses. These include atopic eczema, infantile eczema,

nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus,

lichen planus, intertrigo and psoriasis.

4.2

Dose and method of administration

DIPROSONE Cream and Ointment: Apply a small amount to the affected area twice daily.

For some patients adequate maintenance therapy may be achieved with once daily

application.

In most cases, 4 weeks continuous treatment should be considered the maximum.

Children: Administration of topical corticosteroids to children should be limited to the least

amount compatible with an effective therapeutic regimen.

4.3

Contraindications

Hypersensitivity

betamethasone

dipropionate,

other

corticosteroids

components.

Like

other

topical

corticosteroids,

DIPROSONE

preparations

contraindicated in viral infections of the skin, such as vaccinia, varicella and Herpes

simplex, also tuberculosis, acne rosacea, fungal skin infections (moniliasis), perioral

dermatitis and ulcerative conditions.

4.4

Special warnings and precautions for use

DIPROSONE preparations should not be used in or near the eyes.

If irritation or sensitisation develops, treatment should be discontinued and appropriate

therapy instituted.

In the presence of an infection, an appropriate antifungal or antibacterial agent should be

administered. If a favourable response does not occur within a few days to a week,

DIPROSONE should be discontinued until the infection has been controlled adequately.

S-CCDS-MK1460-DPS-MTL-082017

Corticosteroids are known to be absorbed percutaneously, therefore in patients under

prolonged and extensive topical treatment, the possibility of systemic effects should be

kept in mind. This applies particularly when using the occlusive dressing technique.

Systemic absorption of topical corticosteroids will be increased if extensive body surface

areas are treated. Suitable precautions should be taken under these conditions or when

long-term use is anticipated, particularly in infants and children.

Any of the side effects that are reported following systemic use of corticosteroids, including

adrenal suppression, may also occur with topical corticosteroids, especially in infants and

children.

Patients applying large doses of potent topical corticosteroids over large body surface

areas should be evaluated periodically for evidence of HPA axis suppression. Patients

applying doses of DIPROSONE in excess of 15g per day should be carefully monitored.

Suitable precautions should be taken when using topical corticosteroids in patients with

stasis dermatitis and other skin diseases with impaired circulation.

Prolonged use on flexures and intertriginous areas is undesirable.

Topical

corticosteroid

preparations

produce

striae

atrophy

skin

subcutaneous tissue. If this occurs, treatment should be discontinued. In most cases, four

weeks continuous treatment should be considered the maximum.

Any of the side effects that are reported following systemic use of corticosteroids, including

adrenal suppression, may also occur with topical corticosteroids, especially in infants and

children.

Visual disturbance may be reported with systemic and topical (including, intranasal,

inhaled and intraocular) corticosteroid use. If a patient presents with symptoms such as

blurred vision or other visual disturbances, the patient should be considered for referral to

an ophthalmologist for evaluation of possible causes of visual disturbances which may

include cataract, glaucoma or rare diseases such as central serous chorioretinopathy

(CSCR) which have been reported after use of systemic and topical corticosteroids.

Use in Children

Chronic corticosteroid therapy may interfere with the growth and development of children.

Babies and children up to four years should not be treated with topical steroids for longer

than three weeks. In infants the napkins may act as an occlusive dressing and increase

absorption.

Paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced

HPA axis suppression and to exogenous corticosteroid effects than mature patients

because of greater absorption due to a larger skin surface area to body weight ratio.

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight

gain, and intracranial hypertension have been reported in

children receiving topical

corticosteroids. Manifestations of adrenal suppression in children include low plasma

cortisol

levels

absence

response

ACTH

stimulation.

Manifestations

intracranial

hypertension

include

bulging

fontanelle,

headaches

bilateral

papilloedema.

S-CCDS-MK1460-DPS-MTL-082017

4.5

Interaction with other medicines and other forms of interaction

No data available.

4.6

Fertility, pregnancy and lactation

Use in Pregnancy

Topical corticosteroids should not be used extensively on pregnant patients in large

amounts or for prolonged periods of time.

Use in Lactation

Due to lack of data on the safety of betamethasone dipropionate in lactation, care should

be exercised to ensure that the potential benefits to the lactating mother outweigh the

possible hazards to the nursing infant.

4.7

Effects on ability to drive and use machines

None known.

4.8

Undesirable effects

The following adverse reactions have been reported with the use of topical corticosteroids:

itching, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral

dermatitis, allergic contact dermatitis, maceration of skin, secondary infection, striae and

miliaria.

Systemic adverse reactions, such as vision blurred, have also been reported with the use

of topical corticosteroids.

Rarely reported adverse effects include tingling, prickly skin/tightening or cracking of skin,

warm feeling, laminar scaling and perilesional scaling, follicular rash, skin atrophy,

erythema and telangiectasia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It

allows continued monitoring of the benefit/risk balance of the medicine. Healthcare

professionals are asked to report any suspected adverse reactions:

https://nzphvc.otago.ac.nz/reporting/

4.9

Overdose

Symptoms: Excessive prolonged use of topical corticosteroids can suppress pituitary-

adrenal function resulting in secondary adrenal insufficiency and produce manifestations of

hypercorticism, including Cushing’s disease.

Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid

symptoms are virtually reversible. Treat electrolyte imbalance, if necessary. In cases of

chronic corticosteroid toxicity, slow withdrawal of steroids is advised.

For advice on the management of overdose please contact the National Poisons Centre

on 0800 POISON (0800 764766).

5.

PHARMACEUTICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: betamethasone: ATC code: D07AC01

S-CCDS-MK1460-DPS-MTL-082017

Betamethasone dipropionate is a potent topically active corticosteroid producing prompt

and marked anti-inflammatory, anti-pruritic and vasoconstrictive effects.

According to the McKenzie-Stoughton Vasoconstrictor Test, betamethasone dipropionate

was demonstrated to be significantly more active (p<0.05) than betamethasone valerate,

fluocortolone

flumethasone

pivalate.

While

direct

applicability

this

vasoconstrictor test to clinical situations has not been demonstrated conclusively, the

results showed betamethasone dipropionate to be active in a concentration of 0.000016%,

the lowest concentration tested which showed activity.

5.2

Pharmacokinetic properties

The extent of percutaneous absorption of topical corticosteroids is determined by many

factors including vehicle, integrity of the epidermal barrier and the use of occlusive

dressings. While topical corticosteroids can be absorbed from normal intact skin, dermal

inflammation and/or other dermatological disease processes may increase percutaneous

absorption. Occlusive dressings also substantially increase percutaneous absorption.

After dermal absorption, topical corticosteroids enter pharmacokinetic pathways similar to

those of systemically administered corticosteroids. In varying degrees, corticosteroids are

bound to plasma proteins. They are metabolised primarily in the liver and excreted by the

kidneys. Some topical corticosteroids and their metabolites undergo biliary excretion.

5.3

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that

already included in other sections of the Data Sheet.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

DIPROSONE Cream:

chlorocresol 1mg/g as preservative

soft white paraffin

liquid paraffin

cetostearyl alcohol

cetomacrogol 1000

sodium phosphate monobasic dehydrate

phosphoric acid and

purified water.

DIPROSONE Ointment:

soft white paraffin and

liquid paraffin.

6.2

Incompatabilities

None known.

6.3

Shelf life

Cream: 24 months from date of manufacture

Ointment: 36 months from date of manufacture

6.4

Special precautions for storage

Store below 25°C

S-CCDS-MK1460-DPS-MTL-082017

6.5

Nature and contents of container

Cream: 15g and 50g tube

Ointment: 15g and 50g tube

6.6

Special precautions for disposal

Not applicable.

7.

MEDICINE SCHEDULE

Prescription medicine

8.

SPONSOR

Merck Sharp & Dohme (NZ) Ltd

P O Box 99 851

Newmarket

Auckland 1149

Tel: 0800 500 673

9.

DATE OF FIRST APPROVAL

Cream: 10 June 1976

Ointment: 27 September 1976

10.

DATE OF REVISION OF THE TEXT

03 November 2017

SUMMARY TABLE OF CHANGES

Date

Change

04 September 2017

Reformat data sheet

Addition of special warning and precaution for use: visual disturbance

reported with systemic and topical corticosteroid use

Addition of undesirable effect: systemic adverse reactions such as ‘vision

blurred’

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